a-tDCS Combined With Aerobic Exercise in Healthy Individuals

NCT ID: NCT04211779

Last Updated: 2020-01-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

21 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-03-01

Study Completion Date

2021-12-29

Brief Summary

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The purpose of this study is to assess the effects on the exercise performance of anodal transcranial direct current stimulation combined with aerobic exercise in healthy individuals.

Detailed Description

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Transcranial direct current stimulation (tDCS) is a non-invasive brain stimulation method that has become increasingly popular in recent years. tDCS shows promising improvements for the motor performance of healthy individuals as well as pathological conditions. Moreover, it is frequently preferred because of its safety advantage, high tolerability as well as being cheap, portable and easily applicable.

Studies have shown that tDCS can modulate the excitability of both cortical and subcortical brain regions. In recent years, there have been scientific studies investigating the effects of tDCS on improving physical performance in healthy individuals, but these studies are limited in number, their results are conflicted and as far as the investigators know there is no study that combines tDCS with exercise.

Moreover, although the mechanisms of tDCS on physical performance are largely unknown, some tDCS devices are open to public usage and a large number of professional athletes have reported using tDCS during their training programs. Therefore, studies are needed to demonstrate the effects of tDCS which combined with exercise on performance.

The aim of this study was to investigate the effects of anodal transcranial direct current stimulation combined with aerobic exercise on physical performance in healthy individuals.

Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Real tDCS and Exercise

tDCS (tDCS - TCT Research Limited, Hong Kong) / Exercise Group in which will receive the active intervention of aerobic exercise training and active tDCS intervention at the same time.

Group Type EXPERIMENTAL

Real tDCS

Intervention Type DEVICE

Real tDCS (TCT Research Limited, Hong Kong); 3 times a week on alternate days for consecutive 6 weeks. The active session of tDCS will consist in applying anodal stimulation over left M1 (C3 according to the 10-20 international EEG placement) and the cathodal stimulation over right supraorbital area (Fp2 according to the 10-20 international EEG placement), and to inject 2 mA for 20 minutes through sponge electrodes (35 cm²) placed on the scalp.

Exercise

Intervention Type OTHER

The Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes.

Sham tDCS and Exercise

Sham tDCS (tDCS - TCT Research Limited, Hong Kong) / Exercise Group in which will receive the active intervention of aerobic exercise training and sham tDCS intervention at the same time.

Group Type SHAM_COMPARATOR

Sham tDCS

Intervention Type DEVICE

Sham current (TCT Research Limited, Hong Kong); 3 times a week on alternate days for consecutive 6 weeks. The sham tDCS will use the same montage and device but direct current will only be injected for 30 seconds, with a ramp-up and ramp-down 15 seconds period, to mimic the somatosensory effects of active tDCS.

Exercise

Intervention Type OTHER

The Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes.

Exercise

Exercise group in which will receive the active intervention of aerobic exercise training no tDCS intervention.

Group Type OTHER

Exercise

Intervention Type OTHER

The Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes.

Interventions

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Real tDCS

Real tDCS (TCT Research Limited, Hong Kong); 3 times a week on alternate days for consecutive 6 weeks. The active session of tDCS will consist in applying anodal stimulation over left M1 (C3 according to the 10-20 international EEG placement) and the cathodal stimulation over right supraorbital area (Fp2 according to the 10-20 international EEG placement), and to inject 2 mA for 20 minutes through sponge electrodes (35 cm²) placed on the scalp.

Intervention Type DEVICE

Sham tDCS

Sham current (TCT Research Limited, Hong Kong); 3 times a week on alternate days for consecutive 6 weeks. The sham tDCS will use the same montage and device but direct current will only be injected for 30 seconds, with a ramp-up and ramp-down 15 seconds period, to mimic the somatosensory effects of active tDCS.

Intervention Type DEVICE

Exercise

The Exercise intervention will include only aerobic exercise 3 times a week on alternate days for consecutive 6 weeks. The program will last 20 minutes.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy subject
* No use of any ergogenic substance in one year
* No history of active exercise training in last 6 months

Exclusion Criteria

* Pacemaker
* Intracerebral metallic implant
* Using dietary supplementation or medication potentially affecting the CNS
* Musculoskeletal injury within the past 6 weeks
* Lower extremity pain above 3 or more according to numeric pain scale
* History of epilepsy or convulsive crisis
Minimum Eligible Age

20 Years

Maximum Eligible Age

25 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Marmara University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Mine Gülden Polat, PhD

Role: STUDY_DIRECTOR

Marmara University

Lütfü Hanoğlu, PhD

Role: STUDY_CHAIR

Medipol University

Locations

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Marmara University

Istanbul, , Turkey (Türkiye)

Site Status

Countries

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Turkey (Türkiye)

Central Contacts

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Bahar Ayberk, MSc

Role: CONTACT

00902164140545

Mine Gülden Polat, PhD

Role: CONTACT

00902164140545

Facility Contacts

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Bahar Ayberk, MSc

Role: primary

Other Identifiers

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09.2019.669

Identifier Type: -

Identifier Source: org_study_id

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